Amgen’s Version of Adalimumab Deemed “Highly Similar” to Humira®

If documents written by Food and Drug Administration (FDA) staff members are predictive of the leanings of the Arthritis Advisory Committee, Amgen’s ABP-501 may receive good news this coming Tuesday.

In materials released on Friday, July 8th, FDA reviewers evaluated the clinical study program for Amgen’s biosimilar in patients with rheumatoid arthritis and plaque psoriasis, finding no red flags. The strength of the data may indeed support that this agent is highly similar to Humira. “The results of the clinical development program indicate that Amgen’s data support a demonstration of ‘no clinically meaningful differences’ between ABP 501 and US Humira in terms of safety, purity, and potency in the indications studied,” according to the briefing materials. The Advisory Committee may well start with this position and work towards the question of extrapolation in its Tuesday session.

We will cover the meeting of the Arthritis Advisory Committee on both Tuesday and Wednesday (when it meets to discuss the new biosimilar version of etanercept).